ABVENTURE-P: Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair

Sponsor

Ohio State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05142618

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Location

Arms

29.4

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to evaluate the potential role of physical therapy in improving outcomes after ventral hernia repair.

Condition or Disease	Intervention/Treatment	Phase
Ventral Hernia Hernia Herniorrhaphy Abdominal Wall Postoperative Period Physical Therapy Modalities	Other: Supervised Physical Therapy Other: Post-operative Precautions	N/A

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will perform assessments of several activities of daily living and complete several surveys detailing their pre-surgical abilities, quality of life, and pain. Immediately after their surgical procedure, patients will be randomized in a single-blind manner (investigator) in a 1:1 ratio to supervised physical therapy (8 weeks, twice weekly) or standard post-surgical precautions. Assessments and surveys will be repeated by the blinded investigator at 30 days, 10 weeks, 6 months, and 1 year after surgery.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair

Actual Study Start Date :

Apr 19, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Post-operative Instructions Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions.	Other: Post-operative Precautions This intervention includes standard of care post-operative instructions typically given to patients undergoing ventral hernia repair across the world. These include limiting strenuous physical activity and a lifting restriction of no more than 10 pounds for 6 weeks. Binder use is also encouraged for 4-6 weeks after the operation.
Experimental: Supervised Physical Therapy Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program.	Other: Supervised Physical Therapy The twice-per-week 8-week course of supervised physical therapy begins 2 weeks after surgery. It targets abdominal core function through progressive muscle retraining and strengthening, and patient-specific posture and body mechanics education.

Arm

Intervention/Treatment

Active Comparator: Standard Post-operative Instructions

Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions.

Other: Post-operative Precautions

This intervention includes standard of care post-operative instructions typically given to patients undergoing ventral hernia repair across the world. These include limiting strenuous physical activity and a lifting restriction of no more than 10 pounds for 6 weeks. Binder use is also encouraged for 4-6 weeks after the operation.

Experimental: Supervised Physical Therapy

Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program.

Other: Supervised Physical Therapy

The twice-per-week 8-week course of supervised physical therapy begins 2 weeks after surgery. It targets abdominal core function through progressive muscle retraining and strengthening, and patient-specific posture and body mechanics education.

Outcome Measures

Primary Outcome Measures

Change from Baseline in Five times sit-to-stand time [Baseline before surgery, 10 weeks after surgery]
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function [Baseline before surgery, 10 weeks after surgery]
Computer-adaptive patient-reported questionnaire asking questions about physical function.
Change from Baseline in Quiet unstable sitting test [Baseline before surgery, 10 weeks after surgery]
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.

Secondary Outcome Measures

Change in Hernia related quality of life survey from baseline [baseline before surgery, 10 weeks after surgery]
Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.
Change in Timed Up-And-Go time from baseline [baseline before surgery, 10 weeks after surgery]
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely.
Change from baseline in International Physical Activity Questionnaire - Long Form [baseline before surgery, 10 weeks after surgery]
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.
Change from baseline in Tampa Scale of Kinesiophobia - Short Form [baseline before surgery, 10 weeks after surgery]
Self-reported questions on how fear affects desire and ability to perform physical activities.
Hernia recurrence inventory [1 year after surgery]
Patient-reported questionnaire asking questions regarding a recurrence of the hernia based on pain and presence of a physical bulge.
Change in Hernia related quality of life survey from baseline [baseline before surgery, 1 year after surgery]
Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.
Change in Timed Up-And-Go time from baseline [baseline before surgery, 1 year after surgery]
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely.
Change from baseline in International Physical Activity Questionnaire - Long Form [baseline before surgery, 1 year after surgery]
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.
Change from baseline in Tampa Scale of Kinesiophobia - Short Form [baseline before surgery, 1 year after surgery]
Self-reported questions on how fear affects desire and ability to perform physical activities.
Change from Baseline in Five times sit-to-stand time [baseline before surgery, 1 year after surgery]
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function [baseline before surgery, 1 year after surgery]
Computer-adaptive patient-reported questionnaire asking questions about physical function.
Change from Baseline in Quiet unstable sitting test [baseline before surgery, 1 year after surgery]
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.

Other Outcome Measures

Change in Hernia related quality of life survey from baseline [baseline before surgery, 30 days after surgery]
Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.
Change in Timed Up-And-Go time from baseline [baseline before surgery, 30 days after surgery]
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely.
Change from baseline in International Physical Activity Questionnaire - Long Form [baseline before surgery, 30 days after surgery]
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.
Change from baseline in Tampa Scale of Kinesiophobia - Short Form [baseline before surgery, 30 days after surgery]
Self-reported questions on how fear affects desire and ability to perform physical activities.
Change from Baseline in Five times sit-to-stand time [baseline before surgery, 30 days after surgery]
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function [baseline before surgery, 30 days after surgery]
Computer-adaptive patient-reported questionnaire asking questions about physical function.
Change from Baseline in Quiet unstable sitting test [baseline before surgery, 30 days after surgery]
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.
Change in Hernia related quality of life survey from baseline [baseline before surgery, 6 months after surgery]
Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.
Change in Timed Up-And-Go time from baseline [baseline before surgery, 6 months after surgery]
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely.
Change from baseline in International Physical Activity Questionnaire - Long Form [baseline before surgery, 6 months after surgery]
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.
Change from baseline in Tampa Scale of Kinesiophobia - Short Form [baseline before surgery, 6 months after surgery]
Self-reported questions on how fear affects desire and ability to perform physical activities.
Change from Baseline in Five times sit-to-stand time [baseline before surgery, 6 months after surgery]
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function [baseline before surgery, 6 months after surgery]
Computer-adaptive patient-reported questionnaire asking questions about physical function.
Change from Baseline in Quiet unstable sitting test [baseline before surgery, 6 months after surgery]
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Ages 18+
Diagnosis of ventral hernia
Scheduled for elective ventral hernia repair
Independent functional status
Transverse hernia width of 2cm or greater

Exclusion Criteria

Previously diagnosed movement or balance disorder
Use of ambulatory assistive device (walker or cane)
Physical therapy or other skilled exercise intervention supervised by a medical rehabilitation professional within the past 3 months